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Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer: A Multicentre, Single-arm, Phase II Trial.
Sponsor: Peking University Third Hospital
Summary
Based on the Phase I trial completed by the sponsor, the Phase II clinical trial aims to investigate the effectiveness and safety of image guidance volume-modulated arc radiation therapy concurrently with Nab-Paclitaxel plus Cisplatin for patients with locally advanced cervical cancer.
Official title: Nab-Paclitaxel Plus Cisplatin With Concurrent Radiotherapy for Patients With Locally Advanced Cervical Cancer:A Multicentre, Single-arm, Phase II Trial.
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2024-06
Completion Date
2028-10
Last Updated
2024-05-23
Healthy Volunteers
No
Conditions
Interventions
radiotherapy
Image guidance volume modulated arc therapy included 50.4 Gy in 28 fractions to the pelvis and 59.4 Gy simultaneous boost in 28 fractions to involved pelvic and para-aortic lymph nodes, and subsequent high-dose-rate intracavitary brachytherapy at a total dose of 30.0-36.0 Gy in 5-6 fractions, twice a week.
Nab paclitaxel
Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m\^2) and weekly nab-paclitaxel at escalating doses (33 mg/m\^2 per week).
Cisplatin
Concurrent chemotherapy regimen included weekly cisplatin (40 mg/m\^2) and weekly nab-paclitaxel at escalating doses (33 mg/m\^2 per week).